{"id":17953,"date":"2021-01-08T11:28:07","date_gmt":"2021-01-08T16:28:07","guid":{"rendered":"https:\/\/www.singlecare.com\/blog\/?p=17953"},"modified":"2021-01-08T11:28:07","modified_gmt":"2021-01-08T16:28:07","slug":"fda-approves-glucagon-generic","status":"publish","type":"post","link":"https:\/\/www.singlecare.com\/blog\/news\/fda-approves-glucagon-generic\/","title":{"rendered":"Glucagon generic wins FDA approval"},"content":{"rendered":"

Good news for people with diabetes: You now have a generic option for your glucagon. The U.S. Food and Drug Administration (FDA) has approved the first generic glucagon for injection.<\/span><\/p>\n

RELATED: <\/b>What is glucagon?<\/b><\/a> | <\/b>Glucagon coupon<\/b><\/a><\/p>\n

The FDA announced on Dec. 28, 2020, that it had approved an abbreviated new drug application for glucagon for injection 1 mg\/vial in an emergency kit, manufactured by Amphastar Pharmaceuticals Inc. This generic glucagon kit will give people a new choice for treating severe hypoglycemia, a condition that can impair a person\u2019s ability to function normally.<\/span><\/p>\n

Sally Choe, Ph.D., director of the Office of Generic Drugs in the FDA\u2019s Center for Drug Evaluation and Research, noted the approval is a major step forward for people with diabetes.<\/span>\u00a0<\/span><\/p>\n

\u201cGlucagon for injection has been approved for use in the U.S. for more than 20 years, but until today, there has been no approved generic of this important drug that can save the lives of people who may experience the serious condition of very low blood sugar,\u201d she said in a <\/span>statement<\/span><\/a>.<\/span><\/p>\n

Why it\u2019s important to be prepared for severe hypoglycemia\u00a0<\/span><\/h2>\n

Hypoglycemia occurs when your blood sugar, or blood glucose levels, drop too low. It can range from mild to severe. Mild symptoms may occur when your blood sugar dips below 70 mg\/dL. Moderate symptoms occur when blood sugar drops between 55 and 70 mg\/dL, according to <\/span>JDRF<\/span><\/a>. Symptoms can include feeling a little sweaty, shaky or jittery, tingly, nauseous, hungry, or anxious, as your body reacts to the drop in blood glucose. Mild or moderate hypoglycemia can be treated with glucose tablets or a sugary drink such as juice. These fast-acting carbs can raise blood sugar levels quickly. But that\u2019s not enough to resolve an episode of severe hypoglycemia.<\/span><\/p>\n

When hypoglycemia becomes severe\u2014levels below 40\u201355 mg\/dL\u2014you may lose ability to function or pass out. <\/span>Check with your endocrinologist to determine the blood glucose level considered severe for you. <\/span>Signs of severe hypoglycemia can include difficulty speaking, blurred vision, clumsy or jerky movements, drowsiness, confusion, and even seizures, according to the Mayo Clinic. Severe hypoglycemia<\/span> can develop in people with Type 1 or Type 2 diabetes<\/span><\/a>. However, it\u2019s more common in people<\/span> who take insulin<\/span><\/a> or<\/span> diabetes medications<\/span><\/a> like sulfonylureas.<\/span><\/p>\n

The American Diabetes Association refers to an episode of low blood sugar that requires assistance from others as a \u201c<\/span>severe event<\/span><\/a>.\u201d An injection of glucagon can help quickly raise blood sugar levels. That\u2019s because glucagon is a synthetic version of the hormone produced in the pancreas that stimulates the liver to release stored glucose to bring your blood sugar levels back up.<\/span><\/p>\n

The Glucagen Hypokit, an emergency injection package, starts to raise blood sugar levels within 10 minutes after injection. The most common side effects of glucagon injections are nausea, vomiting, and increased heart rate, as well as some redness or swelling at the injection site.<\/span><\/p>\n

The benefits of a glucagon generic option\u00a0<\/span><\/h2>\n

The approval of the glucagon generic could mean significant savings for people with diabetes who need to keep a kit on hand.<\/span><\/p>\n

You can currently purchase the brand-name<\/span> Glucagen Hypokit<\/span><\/a>, but depending on your insurance, it might cost several hundred dollars. Medicare sometimes covers the cost, and<\/span> coupons<\/span><\/a> are sometimes available to reduce the price.<\/span><\/p>\n

But you may be able to get the new generic version soon. Upon the news of the FDA\u2019s approval, Amphastar announced that it plans to launch its Glucagon for Injection Emergency Kit within two months.<\/span><\/p>\n

\u201c[The] approval reflects the FDA\u2019s continued commitment to advancing patient access to lower-cost, high-quality generic drug products that are as safe and effective as their brand name counterparts,\u201d Choe said.<\/span><\/p>\n","protected":false},"excerpt":{"rendered":"

Good news for people with diabetes: You now have a generic option for your glucagon. The U.S. Food and Drug Administration (FDA) has approved the first generic glucagon for injection. RELATED: What is glucagon? | Glucagon coupon The FDA announced on Dec. 28, 2020, that it had approved an abbreviated new drug application for glucagon […]<\/p>\n","protected":false},"author":85,"featured_media":6927,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[4114],"tags":[72,4141],"coauthors":[9482],"class_list":["post-17953","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news","tag-fda","tag-fda-approvals","wpautop"],"acf":[],"yoast_head":"\nFDA approves new glucagon generic for severe hypoglycemia<\/title>\n<meta name=\"description\" content=\"People with diabetes can start saving money on glucagon injections. 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